Methods of creating a textured breast implant

ABSTRACT

Methods for texturing surgical implants, for example, breast implants, are provided. The methods include applying a tacky layer onto an implant shell, creating a micrometer-scale pattern of sacrificial material on the tacky layer, and thereafter, removing the sacrificial material from the tacky layer to obtain a textured layer. Multiple textured layers can be formed on the implant shell. Further, the micrometer-scale pattern can be formed using a printing mechanism and a 3D printing technique, such as a solid freeform fabrication or a layer manufacturing technique.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application a continuation of U.S. patent application Ser. No. 16/147,472, filed on Sep. 28, 2018, which is a continuation of U.S. patent application Ser. No. 14/703,307, filed on May 4, 2015, now U.S. Pat. No. 10,092,392, which claims the benefit of U.S. Provisional Patent Application No. 61/994,767, filed on May 16, 2014, the entirety of each of which is incorporated by reference herein.

BACKGROUND

The present invention is generally directed to implantable devices, and is more specifically directed to breast implants and methods for creating a textured surface on breast implants.

Breast implants are well known for use in breast reconstruction and for aesthetic purposes, for example, to improving the appearance of the breast. Such implants typically comprise a flexible silicone shell which makes up outer surface of the implant. The shell surrounds a silicone gel or saline filling. Many commercially available implants include so-called “textured surfaces” on the outer surface of the shell. Such textured surfaces are purposefully made to interact with the breast tissue in a healthy manner. Among other things, the type of texture may influence tissue ingrowth and reduce the occurrence of capsular contracture, an adverse event sometimes associated with breast implants.

Several methods for creating a textured surface on an implant currently exist. One method is to use a sacrificial material, for example, salt particles. Salt particles are applied to a silicone shell as the shell is being molded on a mandrel. The particles take up space within the silicone material as the material is being cured. When the sacrificial material is removed (dissolved, melted, etc.), the shell surface has a negative imprint of the original structure of the particles.

Despite many advances in the construction of breast implants, there remains a need for better texturing methods. There has been an interest in developing an optimally textured surface that will affect the breast tissue in the healthiest manner.

SUMMARY

The present invention provides improved methods of making textured surfaces for breast implants. In one embodiment, a method for creating a textured surface on a breast implant generally comprises providing a breast implant shell, applying a tacky silicone layer on the shell, using a computer-controlled deposit mechanism to deposit a texturing material in a predetermined manner onto the tacky silicone layer and removing the texturing material from the tacky silicone layer to obtain a textured surface.

The step of using a computer-controlled deposit mechanism may comprise depositing onto the tacky silicone layer a predetermined number of successive layers of the texturing material. Further, a binder may be applied to one or more predetermined regions of each successive layer of texturing material to cause the texturing material to become bonded at said one or more predetermined regions.

In one embodiment, the texturing material is a sugar. The binder may be an aqueous solution or alcohol.

In another embodiment, the method further comprises the step of applying an additional silicone layer to the deposited layers of texturing material.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be more readily understood, and the numerous aspects and advantages thereof better appreciated, with reference to the following Detailed Description and accompanying Drawings of which:

FIGS. 1A-1C illustrates one process for forming flexible implant shells for implantable prostheses and tissue expanders;

FIG. 2 is a flow chart illustrating a method in accordance with an embodiment of the invention; and

FIG. 3 is a breast implant made using a method in accordance with an embodiment of the invention.

DETAILED DESCRIPTION

Generally, the present invention provides a breast implant, or other soft implant, comprising a shell, for example, a silicone elastomer shell, with a textured surface, and methods for making such implants and textured surfaces. One application for such soft implants is for reconstruction or augmentation of the female breast. Other potential applications for implants that would benefit from having a textured surface are also considered to be within the scope of the invention.

FIGS. 1A-1C illustrates one conventional process for forming flexible implant shells, useful as components of the present invention, for implantable prostheses and tissue expanders. The process typically includes dipping a suitably shaped, e.g., breast implant-shaped, mandrel 20 into a liquid elastomer, e.g., a silicone elastomer dispersion 22. This method may make up some of the preliminary steps in accordance certain embodiments of the invention.

The elastomer dispersion may comprise a silicone elastomer and a solvent. The silicone elastomer may be any suitable biocompatible silicone elastomer, for example, polydimethylsiloxane, polydiphenyl-siloxane or some combination of these two elastomers. Typical solvents include xylene or trichloromethane. Different manufacturers vary the type and amount of the ingredients in the dispersion, the viscosity of the dispersion and the solid content of the dispersion. Nonetheless, the present invention is expected to be adaptable to have utility with a wide variety of elastomers.

The mandrel 20 is withdrawn from the dispersion and the excess silicone elastomer dispersion is allowed to drain from the mandrel. After the excess dispersion has drained from the mandrel, at least a portion of the solvent is allowed to volatilize or evaporate. This may be accomplished by flowing air over the silicone-coated mandrel at a controlled temperature and humidity. Different manufacturers use various quantities, velocities or directions of air flow and set the temperature and humidity of the air at different values. However, the desired result, driving off the solvent, remains the same.

The dip and volatilize procedure may be repeated (e.g., repeating of the steps shown in FIGS. 1B and 1C) a number of times so that a number of layers of silicone are built up on the mandrel to reach a desired shell thickness. A layered structure can be made by sequentially dipping the mandrel in different silicone dispersions. Alternatively, the steps may be repeated in a single dispersion so that a finished breast implant shell 24, for example, prior to the texturing, filling and finishing steps, is a single homogenous material or layer. That is, the dipping process may be done in multiple stages or steps, each step adding more material, yet the shell exhibits no distinct layers and the entire shell wall is homogenous or uniform in composition.

Once the elastomer shell has been stabilized, by allowing volatization, any loose fibers or particles may be removed from of the exterior of the shell, for example, with an anti-static air gun.

At this point, a tack coat layer is sometimes applied to the shell in order to prepare it for a texturing process. The tack coat layer may be sprayed on, or may be applied by dipping the flexible shell on the mandrel into a tack coat material, for example, silicone elastomer dispersion. The shell is immersed into the elastomer dispersion and the mandrel/shell is mounted on a rack for stabilization. The time required for stabilization typically varies between about 5 and about 20 minutes. The tack coat layer may be made using the same material employed in the base layers.

In some prior art processes for texturing implants, after the tack coat layer has been applied, solid salt particles are applied to the tack coat. The solid salt particles are applied by sprinkling particles on the tack coat, or immersing the tack coated shell/mandrel into a fluidized salt particle bath. In this prior art process, the silicone dispersion with salt particles embedded therein, is allowed to stabilize or cure. The salt particles are then removed by placing the shell in a water bath and rubbing the particles out of the silicone shell, thereby resulting in a textured implant shell, which can be filled with silicone gel or saline, and with some further finalizing steps, is packaged for use as a breast implant.

In accordance with one aspect of the present invention, rather than an application of salt particles to the tack coat as generally described herein above, some embodiments of the present invention provides methods of texturing comprising applying a sacrificial material to a tack coat layer by sequential layering of a material to create a desired form or pattern.

In one embodiment, this is accomplished using a computer to create the desired form or pattern from the sacrificial material. The desired form or pattern may be created with computer-aided design technology and/or by using a 3D scanning technology to replicate a desired pattern or form.

Processes in accordance with the invention utilize computer aided manufacturing technology, commonly referred to as solid freeform fabrication (SFF) or layer manufacturing (LM). A LM process typically begins with the representation of a 3D object using a computer-aided design (CAD) model or other digital data input. These digital geometry data are then converted into machine control and tool path commands that serve to drive and control a part-building tool (e.g., an extrusion head or inkjet-type print head) that forms the object, layer by layer. LM processes are capable of producing a freeform object directly from a CAD model without part-specific tooling (mold, template, shaping die, etc.) or human intervention.

LM processes were developed primarily for producing models, molds, dies, and prototype parts for industrial applications. In this capacity, LM manufacturing allows for the relatively inexpensive production of one-off parts or prototypes, and for subsequent revisions and iterations free of additional re-tooling costs and attendant time delays. Further, LM processes are capable of fabricating parts with complex geometry and interiority that could not be practically produced by traditional fabrication approaches. This is especially beneficial for the present invention, in which complex geometries, and hence complex resulting textured surfaces, for example, on a micron-sized scale, can be produced with high precision, in a manner not possible with conventional methods of texturing.

Examples of LM techniques include stereo lithography (SLA), selective laser sintering (SLS), laminated object manufacturing (LOM), fused deposition modeling (FDM), laser-assisted welding or cladding, shape deposition modeling (SDM), and 3D printing (3DP). The latter category includes extrusion and binder deposition technologies.

In one aspect of the present invention, sacrificial material may be “printed” onto the silicone surface of the shell using 3D printing technology, to form a desired pattern or form, which is then removed from the silicone surface to result in a desired surface texture. In some embodiments, the sacrificial material is applied in a predetermined pattern using a computer-controlled deposit mechanism, the predetermined pattern being a model pattern stored in a CAD format.

The sacrificial material may be any suitable material that can be formed on a substrate (e.g., tacky breast implant shell), into a pattern or form, for example, on a micrometer scale, using additive manufacturing technologies, and subsequently removed from the substrate to leave a negative imprint in the desired pattern or form.

After the sequential layering of the sacrificial material, the sacrificial material may then be removed, leaving an imprint or negative space corresponding thereto, for example, cavities and surfaces corresponding to the 3D pattern or form corresponding to the 3D printed sacrificial material.

For example, to perform a print, a machine reads a design from 3D printable file (STL file) and lays down successive layers of material to build the model from a series of cross sections. These layers, which correspond to the virtual cross sections from the CAD model, are joined or automatically fused to create the final shape. One primary advantage of this technique is its ability to create almost any shape or geometric feature. In the breast implant texturing art, this can be especially useful because intricate, well controlled textures, on a micrometer scale, may be created on implant surfaces, for example, textures which provide, at a cell-sized level, a desired architecture for controlling cell ingrowth, collagen fiber development and the like.

In some embodiments of the invention, the method uses binder deposition printing, for example, binder jetting. Such technology may utilize translating powder and binder solutions. U.S. Pat. No. 5,340,656, issued to Sachs et al., describes such a system, the entire disclosure of this document being incorporated herein by this specific reference. A powder-like material (e.g., powdered ceramic, metal, or plastic) is deposited in sequential layers, each on top of the previous layer. Following the deposition of each layer of powdered material, a liquid binder solution is selectively applied, using an ink-jet printing technique or the like, to appropriate regions of the layer of powdered material in accordance with a sliced CAD model of the three-dimensional part being formed. This binder application fuses the current cross-section of the part to previously bound cross-sections, and subsequent sequential application of powder layers and binder solution complete the formation of the desired part.

For example, in embodiments of the present invention utilizing binder deposition printing technology, the sacrificial material may begin as a powder material which is bonded in layers using a suitable binder. The binder may be, for example, any liquid or solution that can be ejected by ejector parts of a binder deposition printing system, and acts to bind the powder material. Suitable binders may include, but are not limited to, aqueous solutions, alcohol, or other suitable liquids. Using binder deposition technology, the printed, bound material is supported at all times during the build process by submersion in surrounding unbound material, which facilitates the production of intricate and delicate geometries. Furthermore, unbound powder can be easily removed and recycled for further use.

For example, the sacrificial material may comprise a sugar. The powder material may comprise a powdered sugar and the binder may comprise a suitable liquid, for example, a starch-containing water. In one embodiment, the sacrificial material is a sugar that is “printed” onto the shell using technology described, for example, in Hasseln, U.S. Patent Publication No. 2013/0034633, which is incorporated herein in its entirety, by this specific reference.

In some embodiments, a system for creating the texture on an implant shell is provided, the system comprising a computer and a texture forming apparatus. The computer may be a general desktop type computer or the like that is constructed to include a CPU, RAM, and others. The computer and texture forming apparatus are electronically connected to a controller.

The texture forming apparatus is used to create the intricate, patterned or formed sacrificial material on the implant shell, as mentioned elsewhere herein.

For example, a printing stratum is applied to the breast implant shell. The printing stratum may comprise a powdered material, such as a powdered salt, sugar, or other suitable material that can be bound with a suitable binder using deposition printing technology.

The texture forming apparatus includes a 3D printing apparatus. The printing apparatus may include components for moving a carriage along a Y-direction and along the X-direction in a plane defined by the X-axis and the Y-axis, as dictated by the controller. The carriage contains a binder cartridge containing binder material, and a binder ejector. The binder ejector is connected to the controller. The cartridge part and its associated ejector are components of the carriage, and are freely movable in the XY-plane. Binder solution is ejected from the ejector and adheres to the specified region(s) of the printing stratum.

Once it has been “printed” onto the shell, the 3D texturing material (sacrificial material) is allowed to set, if needed. It may then be removed from the shell to leave a texture in the shell, for example, in the case where the texturing material is applied to a tacky, not fully cured, silicone layer on the shell.

Alternatively, prior to removing the sacrificial material, an elastomeric dispersion can be applied, for example, in a fine layer, to the printed sacrificial material, and allowed to set or cure. Thereafter, the sacrificial material can be removed by rinsing the shell in water or other solution to cause the material to dissolve from between the elastomer shell and upper layer.

Multiple, alternating layers of elastomer and sacrificial material can be applied to a shell to result in texturing having a desired depth or thickness. An example of a method of the invention using alternative layering is illustrated in FIG. 2.

Using the present methods, it becomes possible to vary the texture on the implant in various thicknesses and in various regions of the breast implant shell. For example, there can be areas of the shell having texture, and areas of the shell having essentially no texture, or less texture.

Texture pattern may be varied from “front” to “back” sides of implant. In some embodiments, the texture is provided on the front, or anterior surface, of the implant, and is reduced or even omitted on the back, or posterior surface, of the implant. In this embodiment, breast tissue adherence may be thus enhanced at the front of the implant and may be reduced on the back of the implant where the implant may contact muscle tissue, for example, when the implant is placed subglandularly.

Breast implants may be placed in the breast in one of several different positions, depending on desired outcome, and/or patient and surgeon preference.

In subglandular placement, the breast implant is placed in a surgically formed pocket directly between the glandular breast tissue and the pectoralis major muscle. This placement most approximates the plane of normal breast tissue. In addition, this placement may offer shorter surgery, less pain and discomfort and perhaps a faster recovery. On the downside, subglandular placement may result in a more palpable implant, a higher chance of visible rippling or folding of the implant, and higher risk of capsular contracture.

In submuscular placement, the breast implant is placed beneath the pectoralis major muscle. Thus, the implant is further away from the skin surface and may be less visible or less palpable. This placement may appear more “natural” because the implant is further away from the skin. It may require a longer surgery and recovery period, but is believed to results in a reduced chance for capsular contracture. In breast reconstruction patients where natural breast tissue may be substantially or entirely absent, this placement approach effects maximal coverage of the implant.

Dual plane breast implant placement is a combination approach in which the implant is placed beneath the pectoralis major muscle, after the surgeon releases the inferior muscular attachments. As a result, the upper portion of the implant is partially beneath the pectoralis major muscle, while the lower portion of the implant is positioned in the subglandular plane. This implantation technique may achieve improved coverage of the upper portion of the implant and allow filling of minor laxity of the lower breast.

Accordingly, in some embodiments, the breast implants in accordance with embodiments of the invention, include distinct regions of texturing, some regions including surfaces more conducive to tissue ingrowth, and some regions including surfaces less conducive to tissue ingrowth.

For example, in some embodiments, an anterior surface of the breast implant shell, that is, the surface facing the front of the patient's body, can have a texture made with the presently described methods, and the posterior side of the implant shell, that is, the surface facing the back of the patient's body, can have less texture or no texture. This embodiment may be most beneficial for subglandular placement of the implant.

Implant 40, shown in FIG. 3, is an example of an embodiment of the invention. The implant 40 is made using methods described herein. As shown, anterior surface 42 of the implant 40 is textured, for example, using 3D printing techniques. Posterior surface 44 of implant 40 has a reduced texture (relative to the anterior surface), or no texture, or a matte texture.

Alternative embodiments, (not shown) include the reverse, for example, in that the anterior surface has no texture, reduced texture or matte texture, and the posterior surface has enhanced texture. Many other variations of texturing distinct patterns or portions of the implant are contemplated and the invention is not limited to the specific ones described herein. For example, Van Epps, U.S. Patent Publication No. 2013/0261745, describes a dual plane implant with an advantageous surface pattern especially useful for the dual plane breast implant placement surgical technique briefly described above. This patent publication is incorporated herein in its entirety by this specific reference.

The present invention allows for creation of a distinct and precise texture pattern (such as a close packed hexagonal pattern) which is not available using conventional breast implant texturing processes. These and other carefully, precisely designed, specific, repeatable texture patterns may be implemented by the use of 3D CAD files—such as, for example, closed hexagonals, nested/tangent circles, rectangles. Furthermore, each implant size and geometry can be tailored to fit with the use of a 3D texturing model both round and ergonomic shaped implants.

Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art without departing from the scope of the invention, as hereinafter claimed. 

What is claimed is:
 1. A method for creating a textured breast implant shell using sacrificial material, the method comprising: creating a first layer of a micrometer-scale pattern of the sacrificial material on a breast implant shell via a three-dimensional printing process; applying a binder to the first layer; creating a second micrometer-scale pattern of an additional amount of the sacrificial material on the first layer via a three-dimensional printing process; and removing the sacrificial material from the breast implant shell to obtain a textured surface, the textured surface being configured to permit ingrowth of cells into the breast implant shell.
 2. The method of claim 1, further comprising curing the first layer before the creating the second micrometer-scale pattern.
 3. The method of claim 2, further comprising removing the sacrificial material from the first layer before the creating the second micrometer-scale pattern.
 4. The method of claim 1, further comprising applying a tacky layer onto the first layer.
 5. The method of claim 4, further comprising curing the tacky layer to form a second layer.
 6. The method of claim 1, wherein the sacrificial material comprises a sugar.
 7. The method of claim 1, wherein the sacrificial material comprises a sugar and a binder in an aqueous solution or alcohol.
 8. The method of claim 1, further comprising obtaining a predetermined thickness of layers by applying additional alternating layers of a tacky layer and sacrificial material.
 9. The method of claim 8, wherein the predetermined thickness varies in various regions on the breast implant shell.
 10. The method of claim 1, wherein the first or second micrometer-scale patterns is one of a closely packed hexagonal pattern, a nested/tangent circle pattern, or a rectangle pattern.
 11. The method of claim 1, wherein the three-dimensional printing process utilizes binder deposition printing.
 12. The method of claim 1, wherein the removing the sacrificial material from the breast implant shell comprises placing the breast implant shell in a water bath and rubbing the sacrificial material from the breast implant shell.
 13. The method of claim 1, wherein the creating comprises forming the micrometer-scale pattern using a solid freeform fabrication (SFF) or layer manufacturing (LM) technique.
 14. A method for creating a textured breast implant shell having a plurality of textured layers thereon, method comprising repeatedly, for each textured layer, performing the steps of: applying a tacky layer onto the breast implant shell; creating a micrometer-scale pattern of sacrificial material on the tacky layer; curing the tacky layer; and removing the sacrificial material from the tacky layer to obtain a textured layer.
 15. The method of claim 14, further comprising obtaining a predetermined thickness of the textured layer by applying the tacky layer and the sacrificial material alternately.
 16. The method of claim 15, wherein the predetermined thickness varies in various regions on the textured layer.
 17. The method of claim 14, wherein the sacrificial material comprises a sugar.
 18. The method of claim 14, wherein the micrometer-scale pattern comprises a hexagonal pattern, a circle pattern, or a rectangle pattern.
 19. The method of claim 14, wherein the removing the sacrificial material comprises placing the breast implant shell in a water bath and rubbing the sacrificial material from the breast implant shell.
 20. The method of claim 14, wherein the creating comprises forming the micrometer-scale pattern using a solid freeform fabrication (SFF) or layer manufacturing (LM) technique. 